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- Title
Palonosetron plus single-dose dexamethasone for the prevention of nausea and vomiting in women receiving anthracycline/cyclophosphamide-containing chemotherapy: meta-analysis of individual patient data examining the effect of age on outcome in two phase III trials
- Authors
Celio, Luigi; Bonizzoni, Erminio; Bajetta, Emilio; Sebastiani, Silvia; Perrone, Tania; Aapro, Matti
- Abstract
Purpose: Data from two randomized trials, evaluating a single-day regimen of palonosetron plus dexamethasone against emesis due to moderately emetogenic chemotherapy, were assessed for the impact of age on outcome in a pooled sample of women receiving anthracycline and/or cyclophosphamide (AC)-containing chemotherapy. Methods: Chemo-naïve breast cancer patients randomized to receive palonosetron (0.25 mg) plus dexamethasone (8 mg IV) on day 1 of chemotherapy ( n = 200), or the same regimen followed by oral dexamethasone (8 mg) on days 2 and 3 ( n = 205), were included in the analysis. The primary endpoint was complete response (CR: no vomiting and no rescue anti-emetics) in the 5-day study period. The effect of the 1-day regimen and age (<50 and ≥50 years) was investigated by a meta-analysis of individual patient data. Results: Younger patients comprised 43 % and 49 % of the 1-day and 3-day regimen groups, respectively; 94 % of the pooled sample received the AC combination. There were no between-treatment differences in CR rate according to age during all observation periods. In the 1-day regimen group, 55.2 % of younger patients achieved overall CR compared with 54 % of older patients. In the 3-day regimen group, 51.5 % of younger patients achieved overall CR compared with 58.7 % of older patients. In the adjusted analysis, younger age was not associated with overall CR to treatment (risk difference, −3.1 %; 95 % CI, −13.0 to 6.7 %; P = 0.533). Conclusions: These results provide evidence that, irrespective of age, the dexamethasone-sparing regimen is not associated with a significant loss in overall anti-emetic protection in women undergoing AC-containing chemotherapy.
- Subjects
DEXAMETHASONE; ANTICIPATORY nausea &; vomiting; ANTHRACYCLINES; CYCLOPHOSPHAMIDE; META-analysis; RANDOMIZED controlled trials; STATISTICAL sampling; BREAST cancer chemotherapy; PREVENTION
- Publication
Supportive Care in Cancer, 2013, Vol 21, Issue 2, p565
- ISSN
0941-4355
- Publication type
Article
- DOI
10.1007/s00520-012-1558-9